Further indications, advantages, reference concentration, specificity and sensitivity, method of detection, sample material, short protocol

Further indications

  • Diagnosis/Exclusion of Acute Pancreatitis
  • Diagnosis of ERCP- or gallstone-induced pancreatitis
  • Follow-up study of acute pancreatitis


In contrast to other laboratory diagnostic parameters for the pancreas, such as amylase and lipase activity in the serum for the diagnosis of acute pancreatitis and faecal chymotrypsin activity for the diagnosis of pancreatic exocrine insufficiency, the determination of pancreatic elastase 1 has the following advantages:

  • E1 is absolutely pancreas-specific.
  • Like other pancreatic enzymes, E1 is released into the blood circulation during an inflammatory episode. Due to its longer half-life, compared to amylase and lipase, its concentration remains elevated longer, and enables detection of an acute pancreatitis even three or four days after onset of the disease.
  • In contrast to amylase and lipase, the serum E1 concentration is only marginally increased in patients with renal insufficiency.

Reference concentration

Values above 3.5 ng elastase/ml serum are pathological.
Values below 3.5 ng elastase/ml serum are normal.

High specificity and sensitivity

Specificity: 96% Sensitivity: 97%

Method of detection

Sandwich ELISA with two monoclonal antibodies highly specific for human pancreatic elastase 1. The ELISA kit is based on a microtiter plate (96 well format) with 12 single strips x 8 wells suitable for up to 41 samples in duplicate.

Sample material

1 ml serum. Undiluted serum samples may be stored for up to five days at 4 – 8°C or up to a year at -20°C.

Short protocol for the experienced user

Important: The short protocol is not a substitute for the detailed protocol given in the instruction manual!

  • Prepare the sample-/washing buffer
  • Dilute serum 1:5 with sample-/washing buffer
  • Pipette 50 µl blank, standards, control and samples in duplicate into the ELISA-strips
  • Incubate 30 minutes at room temperature
  • Wash
  • Add 50 µl anti E1-bio-POD-Streptavidin-Complex (ready-to-use, light sensitive)
  • Incubate 20 minutes at room temperature (in the dark)
  • Wash
  • Add 100 µl substrate solution (ready-to-use)
  • Incubate 20 minutes at room temperature (in the dark)
  • Add 100 µl stop solution (ready-to-use)
  • Read plate at OD 405 or OD 405 – OD 492 between 5 and 30 minutes after addition of stop solution
  • Evaluate with standard curve using a double log scale